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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namereader, cervical cytology slide, automated
Generic Namecervical cytology device
ApplicantNEOPATH, INC.
PMA NumberP950009
Supplement NumberS003
Date Received10/13/1998
Decision Date01/19/1999
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Pathology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the stage three-alarm unit. The device is to be used only on conventionally prepared pap smear slides and is intended to detect slides with evidence of squamous carcinoma and adenocarcinoma and their usual precursor conditions; it is not intended to be used on slides designated by the laboratory as "high risk. " intended users are trained cytology laboratory personnel operating under the direct supervision of a qualified cytology supervisor or laboratory manager/director.